FilmArray Pneumonia Diagnostic Panel: Potential False Positive Results
BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical diagnostic device with the potential for false positive results. No hospitalizations, illnesses, or injuries have been reported. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' yielding a severity score of 3.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray Pneumonia Panel (Pneumo), a diagnostic test kit for pneumonia. The product is classified as an in vitro diagnostic device (IVD) for prescription use. This recall affects 274,290 units.
The FDA has classified this as a Class II recall due to the potential for false positive results when using the pneumonia panel.
The affected product has been distributed worldwide, including throughout the United States and internationally to multiple countries. All unexpired lots bearing UDI 00815381020178 are included in this recall.
The recalled product
- Product
- FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- Affected units
- 274,290
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00815381020178/ All unexpired lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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